Eisai Co., Ltd announced today that an oral presentation highlighting results from a
Phase III clinical study (Study 335) of its in-house developed
antiepileptic drug (AED) perampanel hydrate (global product name:
Fycompa®) in patients with refractory partial-onset seizures conducted
in Asia, including Japan, was given at the 49th Congress of the Japan
Epilepsy Society held from October 30 to 31 in Nagasaki, Japan. In the
study, perampanel demonstrated a significantly higher reduction in
seizure frequency compared to placebo.
In Japan, new drug applications were submitted in July 2015 seeking the approval of perampanel as an adjunctive therapy for partial-onset and generalized tonic-clonic seizures based on the results of Study 335 and other studies.
Study 335 was a Phase III clinical study conducted in Asia, including Japan, to evaluate the efficacy and safety of adjunctive perampanel therapy in 710 patients aged 12 years and older with refractory partial-onset seizures. In this study, eligible patients receiving one to a maximum of three AEDs were randomized to receive perampanel (4 mg, 8 mg or 12 mg) or placebo.
In Japan, new drug applications were submitted in July 2015 seeking the approval of perampanel as an adjunctive therapy for partial-onset and generalized tonic-clonic seizures based on the results of Study 335 and other studies.
Study 335 was a Phase III clinical study conducted in Asia, including Japan, to evaluate the efficacy and safety of adjunctive perampanel therapy in 710 patients aged 12 years and older with refractory partial-onset seizures. In this study, eligible patients receiving one to a maximum of three AEDs were randomized to receive perampanel (4 mg, 8 mg or 12 mg) or placebo.
In the study's primary endpoint of percent change in seizure frequency (per 28 days in the randomization phase relative to the pre-randomization phase), the percent change in the placebo group was -10.8% while in the perampanel (4 mg, 8 mg, 12 mg) groups it was -17.3%, -29.0% and -38.0%, respectively. The difference between perampanel and placebo was statistically significant for the perampanel 8 and 12 mg groups (p=0.0003 for 8 mg, p<0.0001 for 12 mg).
Furthermore, in the study's secondary endpoint of percent change in seizure frequency of secondarily generalized seizures, the percent change in the placebo group was -12.1% while in the perampanel (4 mg, 8 mg, 12 mg) groups it was -17.9%, -45.0% and -52.5%, respectively, demonstrating that perampanel, depending on dosage, reduces seizure frequency in secondarily generalized seizures as well, especially the 12 mg group which showed over a 50% reduction in seizure frequency.
The most common adverse events (>10% in the perampanel groups) observed in the study were dizziness, somnolence and nasopharyngitis.
